Angela N. Johnson PhD, RAC

I am Senior Vice President of Advisory Services at Avania, where I lead the global practice across regulatory, market access, and the dedicated AI/ML and cybersecurity software teams for medtech and combination products. The work is about maximizing investment for our clients and bringing a decade-plus of algorithm and machine-learning experience to bear on regulated industries in the new age of AI.

I held Fortune 50 leadership at Danaher and Cytiva, where I led the QARA (Quality Assurance & Regulatory Affairs) M&A and integration for the Cytiva and Pall medical merger, one of the larger life sciences transformation stories of the era. I also led the QARA integration for the Precision NanoSystems acquisition, pioneering Cytiva's expansion into the lipid-nanoparticle (LNP) space. That work led to one of the first EMA QIG meetings and FDA Advanced Manufacturing Technology (AMT) designations on record.

I spent these years as one of the early voices in artificial organs, implantable bioreactors, and gene/cell therapy regulation broadly. At CTI BioPharma I focused on transplant therapies and novel GCT biologics. At IQVIA MedTech, I was hired as head of regulatory and market access to run the integration and rebrand after the Novella Clinical acquisition was folded into IQVIA, building out the function during the transition. I was the first QARA hire at Sigilon Therapeutics, part of Flagship Pioneering (the venture firm behind Moderna), where I built out the regulatory team from scratch and pioneered the triple-combination genetically modified cell therapy coated with a novel small molecule and encased in an alginate device. That technology exited to Eli Lilly. I carried the GCT work through to Roivant Sciences, leading regulatory for their gene therapy and algorithmic drug candidate programs.

I led machine learning and radiology technology development from research to clinical deployment at GE Healthcare. I supported the first FDA approval of a synthetic MRI algorithm (MAGiC) and shepherded ultrasound needle-guidance algorithms through their first approvals. I won the 2017 American Journal of Neuroradiology Lucien Levy Award for Best Original Research, and took first place at two GE healthcare hackathons (2016, 2017) applying NLP techniques to electronic health records. This is where the AI roots really took hold.

I bridged APAC and FDA regulatory pathways for some of the most complex medical devices, biopharmaceuticals, and robotic surgery platforms in the market. I worked with the previous CFDA (now NMPA) via Medsci Bioon Group, building the global and Asia-Pacific regulatory knowledge that still shapes how I think about cross-jurisdictional strategy today.

I did hands-on IT security work at EIS Data Systems, including substantial government contract work that planted the compliance roots I built everything else on. In parallel, I held design and engineering management roles at Queensboro, Parrott, and others, supplying named manufacturers including Corning, Grady-White, and Thermo Fisher. The years where the discipline of regulated work became muscle memory and where the engineering instinct met the security mindset.